Three dimensional radiation image reconstruction

ABSTRACT

X-ray devices and systems are described in this application. In particular, this application describes x-ray devices and systems that are used for three-dimensional (3D) image reconstruction with uncertain geometry. The x-ray imaging system contains an arm configured to be moved around an object to be imaged, a light weight, low power x-ray source attached to the arm, an x-ray detector configured to move complimentary to the x-ray source to capture multiple two-dimensional (2D) images in a solid angle path outside of a planar arc, 3D position and orientation tracking device(s) configured to capture the geometric position and orientation of the x-ray source and detector when each 2D projection image is captured, and a processor configured to construct a three dimensional (3D) image from the multiple 2D images using a reconstruction algorithm. These x-ray systems are lighter, more maneuverable, and less expensive than conventional CT x-ray systems because the geometry tracking devices combined with the processor and algorithm enable the generation of 3D images without the complex, precise, heavy, and expensive mechanical system that fixes the precise geometry of each 2D projection image to a high degree of accuracy. Other embodiments are described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. Application SerialNo. 17/052,137, filed on Oct. 30, 2020, which is a national stageapplication of PCT/US2019/018574, filed on Feb. 19, 2019, which claimspriority of U.S. Provisional Application Serial No. 62/631,569 filed onFeb. 16, 2018, the entire disclosures of which are incorporated hereinby reference.

FIELD

This application relates generally to X-ray equipment. Morespecifically, this application relates to x-ray devices and systems thatare used for three dimensional (3D) image reconstructions with uncertaingeometry.

BACKGROUND

X-ray imaging systems typically contain an X-ray source and an X-raydetector. X-rays are emitted from the source and impinge on the X-raydetector to provide an X-ray projection image, or a shadow image, of theobject or objects that are placed between the X-ray source and thedetector. The X-ray detector is often an image intensifier or even aflat panel digital detector.

X-ray imaging systems have been developed that produce either 2D or 3Dimages. The imaging systems that produce 3D images typically employcomputed tomography techniques to reconstruct a 3D image from multiple2D images. These 3D X-ray systems are typically large and expensive, anddeliver a higher radiation dose to the patient because of the numerousx-ray projection images required for the reconstruction calculations.They are used judiciously because of the expense and the inconvenienceof obtaining a 3D image. Other concerns with such 3D imaging systems arethe high radiation dose delivered to the patient. Thus, 3D imagingsystems are not used in many instances where patients would benefit fromthe additional detail and insight that can be provided by 3D images ifthey were more readily available.

SUMMARY

This application relates generally to x-ray devices and systems. Inparticular, this application describes x-ray devices and systems thatare used for three-dimensional (3D) image reconstruction with uncertaingeometry. The x-ray imaging system contains an arm configured to bemoved around an object to be imaged, a light weight, low power x-raysource attached to the arm, an x-ray detector configured to movecomplimentary to the x-ray source to capture multiple two-dimensional(2D) images in a solid angle path outside of a planar arc, 3D positionand orientation tracking device(s) configured to capture the geometricposition and orientation of the x-ray source and detector when each 2Dprojection image is captured, and a processor configured to construct athree dimensional (3D) image from the multiple 2D images using areconstruction algorithm. These x-ray systems are lighter, moremaneuverable, and less expensive than conventional CT x-ray systemsbecause the geometry tracking devices combined with the processor andalgorithm enable the generation of 3D images without the complex,precise, heavy, and expensive mechanical system that fixes the precisegeometry of each 2D projection image to a high degree of accuracy.

BRIEF DESCRIPTION OF THE DRAWINGS

The following description can be better understood in light of theFigures which show various embodiments and configurations of the imagingsystems and methods. Together with the following description, theFigures demonstrate and explain the principles of the structures,methods, and principles described herein. In the drawings, the thicknessand size of components may be exaggerated or otherwise modified forclarity. The same reference numerals in different drawings represent thesame element, and thus their descriptions will not be repeated.Furthermore, well-known structures, materials, or operations are notshown or described in detail to avoid obscuring aspects of the describeddevices.

FIG. 1 shows a view of some embodiments of small, portable X-raydevices;

FIG. 2 shows another view of some embodiments of small, portable X-raydevices;

FIGS. 3A and 3B show a view of some embodiments of the range of motionof small, portable X-ray devices;

FIG. 4 shows another view of other embodiments of the range of motion ofsmall, portable X-ray devices;

FIG. 5 shows another view of some embodiments of small, portable X-raydevices containing tracking devices;

FIG. 6 illustrates an example of the planar arc acquisition path of someconventional CT imaging processes;

FIG. 7 illustrates some embodiments of a less-constrained ornon-constrained acquisition path that covers a region of a solid angle;

FIG. 8 shows a sample three-dimensional acquisition path (projected intwo dimensions) of an x-ray system during a possible data scan;

FIG. 9 shows an exemplary axial slice of a 3D reconstruction imageobtained using tracking data;

FIG. 10 shows an axial slice obtained using a CT image and acorresponding simulated 3D reconstructed image; and

FIG. 11 shows some embodiments of the small, portable X-ray devicescontaining an external tracking device(s).

DETAILED DESCRIPTION

The following description supplies specific details in order to providea thorough understanding. Nevertheless, the skilled artisan willunderstand that the described X-ray systems can be implemented and usedwithout employing these specific details. Indeed, the described systemsand methods can be placed into practice by modifying the describedsystems and methods and can be used in conjunction with any otherapparatus and/or techniques conventionally used in the industry. Forexample, while the description below focuses on imaging systems usingx-rays, other forms of electromagnetic or atomic radiation could beused, including gamma rays, neutron radiation and infra-red or visiblelight, depending on the absorptive characteristics of the objects to beimaged by the desired radiation. Ultrasonic energy could also be usedwith the appropriate sources and detectors to generate 3D images in asimilar manner. In another example, while the description below focuseson c-arms, other system configurations that hold the x-ray source anddetector in a fixed position relative to one another while they aremoved around the object during an imaging scan, such as O-arms, could beused successfully. It is even possible to move the x-ray source anddetector independently around an object during an imaging scan as longas the 3D position of each is accurately recorded for each image, thoughthis might complicate the image reconstruction process and may result inundesirable reconstruction artifacts in the 3D image, or perhaps requiretoo much computing power and time to generate a 3D image in a usefultime frame given current computer technology.

In addition, as the terms on, disposed on, attached to, connected to, orcoupled to, etc. are used herein, one object (e.g., a material, element,structure, member, etc.) can be on, disposed on, attached to, connectedto, or coupled to another object-regardless of whether the one object isdirectly on, attached, connected, or coupled to the other object orwhether there are one or more intervening objects between the one objectand the other object. Also, directions (e.g., on top of, below, above,top, bottom, side, up, down, under, over, upper, lower, lateral,orbital, horizontal, etc.), if provided, are relative and providedsolely by way of example and for ease of illustration and discussion andnot by way of limitation. Where reference is made to a list of elements(e.g., elements a, b, c), such reference is intended to include any oneof the listed elements by itself, any combination of less than all ofthe listed elements, and/or a combination of all of the listed elements.Furthermore, as used herein, the terms a, an, and one may each beinterchangeable with the terms at least one and one or more.

FIG. 1 shows some embodiments of small, portable X-ray devices 100 thatcan be used in the x-ray systems described herein. Generally, theportable X-ray devices 100 contain an imaging arm that allows the systemto be used to take X-ray images of a portion of a patient’s body or anyother object capable of being analyzed by x-rays, including animals,industrial components such as electronic circuit boards, containers tobe inspected, and/or passenger luggage. In some configurations, theimaging arm is substantially shaped like the letter “C” and is thereforereferred to as a C-shaped support arm (or C-arm) 105. The C-arm has anysize that can be held and operated by hand when in use, as seen in FIG.1 .

The C-arm 105 can contain any X-ray source 135 and X-ray detector 140that allow the X-ray system 100 to take X-ray images. The X-ray source135 can contain any source that generates and emits X-rays, including astandard stationary anode X-ray source, a micro-focus x-ray source, arotating anode x-ray source, and/or a fluoroscopic X-ray source. And theX-ray detector 140 can contain any detector that detects X-rays,including an image intensifier, a CMOS camera and/or a digital flatpanel detector. In some configurations, the detector can have asubstantially square shape with a length ranging from about 13 cm toabout 15 cm. In other configurations, the detector can have asubstantially rectangular shape with the shorter dimension ranging from12 cm to 16 cm, and the longer dimension ranging from 18 cm to 24 cm.The X-ray source 135 can be contained in a housing that can beconfigured in two parts with a first part enclosing the x-ray source 135and a second, separate part enclosing the x-ray detector 140. In otherconfigurations, however, the housing can be configured so that it is asingle part that encloses both the X-ray source 135 and the X-raydetector 140.

In some configurations, the housing can also enclose a removable powersource (such as a battery) and optionally a power supply. Thus, thepower source and the power supply can be located internal to the housingand also to the x-ray device 100. The supporting electronics for thepower source and the power supply, as well as the supporting electronicsfor an image display and for wireless data upload, can also be locatedinternal to the housing. Thus, in these configurations, the x-ray device100 does not contain an external power cord or data cable. Incorporatingthe power source (i.e., the battery), the power supply, and thesupporting electronics all within the housing allows the size and theweight of the device to be reduced. With such a configuration, the powersource can easily be replaced (or hot-swapped) and delivers 60 or morex-ray images using a single charge. Of course, if needed, the x-raydevice can be configured so that it is alternately, or additionally,charged using external power from a power cord that is plugged into awall outlet. In other configurations, multiple power supplies can beprovided for the source, detector, and control electronics, any (or all)of which can be located either internal or external to the housing.

The X-ray device 100 also contains a frame 150 that has an openconfiguration. As shown in FIG. 1 , an open configuration gives a numberof easy gripping options for a user to carry and hold the frame 150during transport, and optionally during operation of the x-ray device100. In some embodiments, the frame 150 can be configured as a modularunit so different cross members (or length member or handles) can beused to replace the existing cross members (or length member orhandles). Thus, the frame 150 provides the ability for a user (oroperator) to grip and hold the X-ray device 100 during operation, afeature that is useful since other conventional C-arms can’t be held inthe hands while being operated because they do not have a suitable frameand because they are too heavy.

In other embodiments, the portable x-ray device has the configuration asillustrated in FIG. 2 . In the embodiments of FIG. 2 , the frame 150 hasa first portion 155 that is part of the housing that also contains thex-ray source 135 and the associated electronics. The frame 150 also hasa second portion 160 that is part of the housing that also contains thex-ray detector 140 and the associated electronics. The first portion 155of the housing and the second portion 160 of the housing are connectedusing hinge 165. The bottom of the portable x-ray device can contain anopening 175.

The portable x-ray device 100 has several features not exhibited byother C-arm devices. First, it has the capability of wireless datatransfer, thereby eliminating the need for any wired connections or datacables to the C-arm. Second, it is internally powered by a battery orinternal power source and, therefore, more portable than other C-armdevices which require a power cable. Third, it is lighter that otherC-arm devices. As a comparison, the portable x-ray C-arm devices 100described herein can have a weight ranging from about 10 to about 25pounds while other C-arm devices have a weight ranging from about 35 toabout 375 pounds. In other embodiments, the portable x-ray C-arm devices100 described herein can have a weight ranging from about 12 to about 18pounds.

In some embodiments, the frame 150 can be connected to an external (orsupport) structure so that it can rotate around an object beinganalyzed, as shown in FIGS. 3A and 3B. In these embodiments, theconnection between the frame 150 and the external structure contains ajoint 210 that allows the following three functions. First, the joint210 can be attached to the C-arm 105 and the support structure so thatthe C-arm 150, similar to other conventional C-arms, can rotate aroundthe object (i.e., from the position in FIGS. 3 to the position in FIG. 4) being analyzed (i.e., the arm of a patient). Second, the joint 210allows the X-ray device to be quickly and easily attached (and detached)from the external structure. And third, the joint 210 allows theconnection between the X-ray device 100 and the external structure to belocated at any desired location of the frame (e.g., at 15, 30, 45, 60,75, 90, 105, 120, 135, 150, and 165 degrees along the arc of the C-arm,or at any location therebetween). For example, as shown in FIG. 3A thejoint 210 is connected to x-ray device 100 at about 90 degrees along thearc of the C-arm while in FIG. 3B the tri-joint 210 is connected tox-ray device 100 at about 60 degrees. Besides these motions, the C-arm150 can slide along a sector bearing, or “nod” around the object, tocapture the 2D images as shown in FIG. 4 .

FIGS. 3A, 3B, and 4 show some embodiments in which the joint 210 isattached at one end to the frame 150 of X-ray device 100 and at theother end to an extension 215 that extends from the external structure.In the embodiments shown in FIGS. 3A and 3B, the external structurecomprises a supporting base 220 to which the extension 215 is connected.The support structure can also contain any other medical components andelectronic components, as described herein, like the display 360 and theuser interface 355 shown in these Figures.

In the configurations shown in FIGS. 3A, 3B, and 4 , the x-ray systemcan include a motion-controlled stage or support arm. This stage maycomprise mounting the C-arm device to a sector bearing spanning anangular range of approximately 200°, as depicted in FIGS. 3A, 3B, and 4. The C-arm can be positioned with the target area of the patient (afoot, knee, etc...) at the approximate center of rotation. The C-arm canthen be scanned through this arc over the desired amount of time rangingfrom about 3 to about 10 seconds. In some embodiments, this time isapproximately 5 seconds.

In some embodiments, the x-ray devices and systems can be configuredsimilar to the C-arm device shown in FIG. 5 . In these embodiments, theelectronics can be modified for the special purpose of 3D imaging byincluding a tracking mechanism into the x-ray device. In someconfigurations, the tracking mechanism can be integrated into either theC-arm or other mechanical structure that positions the X-ray source andthe X-ray detector relative to one another. In other configurations, thetracking mechanism can be external to the C-arm or other mechanicalstructure that positions the X-ray source and the X-ray detectorrelative to one another. In yet other configurations, the trackingmechanism can be located in any mechanical structure that supports theC-arm. The tracking mechanism can be configured to track and record theposition and orientation of the x-ray system, including the x-ray sourceand/or detector for each 2D projection of the object taken along theimage acquisition trajectory.

In some configurations, tracking devices 180, including MEMS inertialtracking devices, can be mounted in the C-arm as shown in FIG. 5 toprovide geometric position information when each image frame acquired.These tracking devices can be mounted in at least 2 separate positions,one near the x-ray source and the other near the x-ray detector in orderto provide the position information for both the x-ray source anddetector. Depending on the type of tracking device used (whether or notthe tracking devices can accurately track orientation as well asposition), a third tracking device may need to be placed at a thirdlocation in the arm in order to determine the orientation of thecomponents of the x-ray system for each 2D x-ray projection image takenduring the scan. In other embodiments, the tracking devices can beincluded in other locations of the x-ray system, such as on more distalportions of the x-ray source and detector as well as further along thearm of the C-arm. Indeed, any number of tracking devices could beincorporated into the C-arm, provided that at least one tracking deviceis located near the source and one near the detector.

In some configurations, the tracking devices 180 depicted in FIG. 5should meet certain accuracy requirements in order for the 3Dreconstruction to be successful with the necessary resolution. As anexample of the type of tracking device that could serve this purpose,MEMS tracking devices from a variety of vendors are available for avariety of purposes and can be used, but may not always deliver theneeded resolution. A tracking device that can accurately and repeatablyreport the 3D position to within about 0.5 mm of the X, Y, and Zpositions should be sufficient. Of course, with improvements in thecomputational speed of the graphical processor or other extremelyhigh-speed computational device, it may be possible to relax thisrequirement and still achieve the desired 3D reconstruction performance.As well, it may also be possible to reduce the computational requirementby achieving better accuracy than the 0.5 mm requirement mentionedabove. Therefore, an accuracy of about 1.0 mm, about 0.75 mm, about 0.5mm, about 0.25 mm, or even about 0.1 mm may be practical and used insome embodiments. In other configurations, this accuracy can be anycombination, sub-combination, or range of these amounts.

Tracking devices can also be used to know the orientation of the X-raysource and the detector for each image in the sequence as their locationand orientation progressively changes from image to image from aninitial starting position. Depending on the choice of the trackingdevice to be used, the orientation can be determined by comparing theposition of at least three different tracking devices and calculatingthe relative orientation from image to image directly from the 3Dinformation provided by each tracking device. This calculation ispossible because the C-arm is a substantially rigid structure with aknown configuration that can be relied upon to keep the relativeposition of the tracking devices constant to within a tolerance of about0.25 mm, about 0.20 mm, about 0.1 mm, about 0.05 mm, about 0.01 mm oreven less from image to image. In other configurations, this tolerancecan be any combination, sub-combination, or range of these amounts.

In these embodiments, the tracking devices 180 can also provideorientation information as well as 3D position information. It isbelieved that an orientation accuracy on the order of about 0.5 degreeof the solid angle will be sufficient during the 3D imaging process.Again, relaxing or tightening this tolerance should be possible and isbelieved to involve a trade-off between computing power, reconstructiontime, and accuracy. Therefore, an orientation accuracy of less thanabout 2 degrees, about 1 degree, about 0.75 degrees, about 0.5 degrees,about 0.25 degrees, or about 0.1 degree of the solid angle is believedto be practical and functional in various embodiments. In otherconfigurations, this orientation accuracy can be any combination,sub-combination, or range of these amounts.

As noted herein, the tracking devices can include MEMS inertial trackingdevices. Other examples of tracking devices that can be used includeaccelerometers, light sensors, optical cameras, magnetic field sensors,and/or electromagnetics sensors. The types of light sensors that can beused include infrared sensors, ultraviolet sensors, and/orradio-frequency sensors.

In other embodiments, the tracking mechanism can include a trackingdevice(s) that is not located in a position on the C-arm that positionsthe X-ray source and the X-ray detector relative to one another. Theseexternal tracking devices may be any of the tracking devices listedherein. One example of these external tracking devices is shown in FIG.11 where external tracking devices 77 are located in the ends of thelegs of the supporting structure holding the C-arm. Another example ofthese external devices are those that are not contained on themechanical support structure shown in FIG. 11 , such as tracking devicesthat could be located in the proximity of the objection being analyzed(object 78).

In other embodiments, the external tracking devices may include afiducial marker or an arrangement of fiducial markers. A fiducial marker(or fiducial) is an object placed in the field of view of an imagingsystem that appears in the image produced, for use as a point ofreference or a measure. It may be either something placed close to,into, or on the object to be imaged.

The accuracy of these 3D x-ray imaging systems can be improved usingthese fiducial markers. In order to reconstruct 3D images usingtomosynthesis techniques or other mechanisms for assembling 3D images,it is important to know where the x-ray source is on a path in relationto the X-ray detector. While many of these paths are predetermined,small variances in patient location can result in minor deviations fromthe desired path on a frame-to-frame basis. These errors can be compoundin a tomosynthesis process, resulting in a compounding loss of qualityin a final 3D image assembled from the 2D X-ray images. In order toaccount for these small variances in detector position, the geometriclocation of the X-ray source can be independently calibrated withrespect to the detector for each 2D X-ray image by using the fiducialmarker(s).

In some configurations, the fiducial marker may comprise one or moresmall balls or spheres positioned somewhere in the field of view foreach 2D X-ray projection image. This type of marker can be placed insuch a way that each of the spheres is part of an arrangement ofspheres, where the distances from one sphere to the next are known to ahigh degree of precision relative to the pixel size of the 2D images. Adata file can then be developed that holds the locations of each objectin the array, linking that to the X-ray source and detector combination,describing the locations of the spheres in the array.

As well, the fiducial marker(s) may be used with an external devicecoupled to the x-ray imaging device or by just utilizing a marker placedexternal to the x-ray device, such as a medical instrument (e.g., acatheter), or even near the object being analyzed such as a table wherea patient is located. In other configurations, the array of fiducialmarkers can be incorporated into an object that is combined with-or heldby-the housing containing the x-ray sensor/detector. Since the marker(s)will usually be located at the region of interest, this increases theaccuracy of detection in this region, and thus improves the threedimensional reconstruction quality.

In some embodiments, an arrangement(s) of fiducial markers can be used.Specifically, the arrangement of markers can be positioned external tothe C-arm. The arrangement of markers can be positioned such that each2D image includes a projection of at least a portion of the arrangementof markers. The location of the source and/or detector of the x-raydevice associated with the identified marker may be then determinedwhile capturing the x-ray image.

In some embodiments, the arrangement(s) of markers can comprise an arrayof at least two fiducial markers. In such embodiments, each marker canbe formed to have a cross-section in the shape of a circle, rectangle,rhombus, pentagon, hexagon, octagon, and/or polygon. The markers may behomogenous across or within the array, or the markers may differ acrossor within the array. A variety of marker shapes could be used atdifferent points in the array.

The sizes of the markers can vary widely. They need to be small enoughto have a significant number of markers in the image, but large enoughthat they are easy to detect. In some configurations, the sizes of themarkers can vary across the array.

The x-ray systems described herein can be configured in some embodimentsto be guided by a mechanical device positioned at the side of theoperating room (OR) table (or other desired location) to gather theneeded set of 2D projection images for the 3D reconstruction. In theseembodiments, the purpose of the mechanical guidance mechanism is tosimplify the task of the operator in appropriately capturing the needed2D images by allowing the operator to move the x-ray systems on amechanical guide or support by hand. This makes it easier for theoperator in many cases since the weight of the system is born by themechanical guide. It also makes it easier in that the operator does nothave to move their arms and hands around the patient in ways that mightbe difficult or that might require the operator to position themselvesawkwardly above the patient in order to cover the entire range of anglesdesired.

In other embodiments, the x-ray system can be guided by hand through therange of solid angles needed to reconstruct the desired 3D image. Thiswould be straightforward in many instances, such as when a patient isstanding upright and the x-ray system is moved around the patient’s kneeby hand, or similarly when a 3D image of an ankle or elbow is needed.Whether or not a mechanical guide is used would be determined by thephysician based on the particular circumstances of each case.

The x-ray systems use high-powered, multi-threaded, multi-processorgraphical processing units to render a 3D image quickly. In mostapplications, such as in the OR, it will be desirable to provide thereconstructed 3D image in less than two minutes, or even a minute. Byadding additional processors or with improved software and otherprocessing techniques, the 3D image can be rendered in less than about45 seconds or perhaps even less than about 30 seconds. Of course, therendering speed for a particular #D image will be determined by theacceptable trade-off between cost and rendering time.

The x-ray systems described herein also have a small footprint and asmall size. Thus, instead of 3D images being obtained only with aspecial, large, and expensive CT apparatus used only when the costs canbe justified, 3D images from these x-ray systems can be quickly andeasily obtained. While the initial uses of the x-ray system will be toimage specific parts of a patient (i.e., orthopedic surgeries and othersimilar applications), it can also include full-body imaging capabilitywith x-ray sources that can provide the requisite x-ray energy and flux.

The x-ray systems described herein can be used for 3D imaging ofpatients similar to Computed Tomography (CT). CT is a common 3D imagingprocedure used for diagnosis and treatment of fractures and for othersurgical and medical procedures. Unfortunately, some current CTequipment doesn’t meet the needs of many medical situations, includingdiagnostic requirements and surgical procedures, especially insituations that need a rapid response such as treating the victims of anaccident or other emergency. This situation can occur because the CTequipment and facility is at a different location, or the difficulty anddelay in conveying the patient to the CT facility makes obtaining 3Dimages impractical, especially when “before and after” images aredesired to assess the results of a surgical procedure. This situationcan also be caused by the expense of current CT equipment, because it isnot cost effective to maintain CT equipment in every operating room orclinic.

Unlike some conventional CT systems, though, the x-ray systems describedherein can be used for fast, accurate, low-cost, low-dose, andminimally-disruptive 3D imaging systems for use in and out of theoperating room. In some embodiments, the x-ray systems described hereinare referred to as Flexible 3D Computed Tomosynthesis (or F3CT) systems.The F3CT systems enable the 3D imaging mechanism to be brought to thepatient, irradiate only the target area, provide immediate results, andenable the user or operator (i.e., surgeon or other medical personnel)to verify the 3D alignments and proper positioning of bone fractures,medical instruments, implants, or other objects or body parts needed toobtain the medically-desired results and to identify any defects orproblems during the medical procedure, rather than afterward when it isnot possible to correct the error or defect. The F3CT systems do notrequire the patient to be repositioned, or other equipment and personnelto be displaced during the procedure. Instead, these F3CT systems use asmall, lightweight x-ray device which is easily stored and can becarried by hand (or moved on a small cart) to the side of the patient.The F3CT systems can be maneuvered around the affected limb, shoulder,or other body part in a prescribed manner (i.e., complete 360° coverageis not required) to capture the necessary 2D projections with the X-raysource and the detector following a path that covers a region of solidangle. The 3D reconstructed image can be presented within a short periodof time (less than a minute or so) on a display screen.

Some current inter-operative imaging systems use conventional fan-beanor cone beam CT processes. These systems collect x-ray projection imagesby rotating the x-ray source and the detector in a strictly constrainedcircular fashion around the object to be imaged, as shown in FIG. 6 . Asshown in this Figure, the source 135 and 140 are located on oppositesides of an object 300 that is being imaged. The source 135 and detector140 are linked by a mechanical structure (such as a C-arm) that is notshown in FIG. 6 . The x-rays 330 emanate from the source 135, impinge ona region 310 of the object 300, and then strike the detector 140. Themotion of the source 135 is confined to a plane and describes a circlein that plane. As shown in FIG. 6 , the arrows 340 are part of a circlethat lies in a plane oblique to the page with a normal to the planedefined by axis 320 with the center of the circular arc located withinthe object 300. The process uses an axis of rotation 320 that isperpendicular to this planar arc 360. This collection process leads tothe large toroidal shapes that are typical of conventional CT systems.

Unlike these CT systems, the F3CT systems (and the x-ray systemsdescribed herein) can have a flexible data acquisition trajectory thatcover or traverses a region of solid angle rather than following asubstantially constant-radius arc that is confined to a particularplane. Such embodiments are illustrated in FIG. 7 . As shown in thisFigure, the source 135 and 140 are located on opposite sides of anobject 400 that is being imaged. The source 135 and detector 140 arelinked by a mechanical structure (such as a C-arm) that is not shown inFIG. 7 . The x-rays 430 emanate from the source 135, impinge on a region410 of the object 400, and then strike the detector 140. Rather thanjust being limited to rotating in a planar arc, though, the source 135(and therefore also the detector 140 which is mechanically linked to thesource 135) traverses or samples a region 420 of solid angle along anarbitrary path 450. There can be any number of paths that are possibleand path 450 is illustrated in FIG. 7 for exemplary purposes only. Suchan approach in these embodiments increases the challenge of imagereconstruction since many data acquisition trajectories are possible andit can be difficult to precisely measure or track them. The F3CT systemsaccordingly use the internal or external tracking mechanisms describedherein, as well as massive computing power now available in a graphicalprocessing unit (GPU), to relax the mechanical constraints caused by therequirement to exactly know the scan geometry and to constrain it to asubstantially constant-radius arc or series of arcs in one or morerelated substantially-parallel planes used in CT systems. In the F3CTsystems, the constraints on the acquisition trajectory can be relaxed,thereby enabling an acquisition trajectory that covers or traverses aregion of solid angle so that adequate 2D projection image data isobtained to provide a high-resolution reconstruction in all 3dimensions, and computing power is used to solve the resulting complexreconstruction calculations.

The x-ray systems described herein can be configured as an ultra-compactC-arm (or other suitable mechanical configuration) that is hand-portableand/or hand-held when used. In these configurations, the weight shouldbe minimized as much as possible, and can even be as light as about 15lbs (7 kg). Of course, a variety of weights is possible, depending onthe exact configuration of the C-arm, as long as the weight is not somuch that it is impractical to be used as a hand-held device. Therefore,the weight might be about 25 lbs (12 kg), or about 20 lbs (9 Kg), oreven perhaps as low as 10 lbs (4.5 Kg) in various configurations. Theultra-compact C-arm is suitable for use in any desired location,including the OR, surgical clinic, examination rooms, and other medicalsettings such as sports medicine, military field-hospital use, andemergency medicine settings such as at the scene of an accident or anatural disaster.

The x-ray systems described herein can contain a battery-operated x-rayimaging system with a 1500 × 1500 pixel, 100 µm resolution CMOS x-raydetector with a Cesium Iodide (CsI) scintillator. The use of a CsIscintillator provides for high sensitivity to x-rays and enables a lowerdose to the patient. Of course, other detector technologies arepossible, such as zinc selenide scintillators, CCD arrays, or otherflat-panel detector array technologies that are known to those in theart.

In some configurations, the x-ray systems described herein can bedesigned for extremity imaging, with a source to detector distance ofabout 14 inches. Other configurations are possible within theconstraints of the desired weight and size to allow for portability andoperation by hand. Accordingly, the X-ray source to detector distancecan vary anywhere from approximately 10 inches (25 cm) up toapproximately 25 inches (64 cms), up to perhaps as much as about 30inches (76 cm) but in some configurations the X-Source to X-ray detectordistance be between about 12 inches (30 cm) to about 18 inches (46 cm).Of course, the detector size and the cone-angle or angular spread of theX-rays emitted by the x-ray source will need to be adjusted as thisdistance is changed so that the emitted X-rays fill the entire detectoraperture, but do not extend appreciably beyond the edges of thedetector.

In some embodiments, the detector size may be changed in order to matchthe size of the detector to the area illuminated by the X-ray source.However, it is not practical that the detector be too large becauseeither this will required such large pixels in the detector that theresolution will be inadequate, or that there will be so many pixels inthe 2D projections that the reconstruction of the 3D image will becomeimpractical within the desired reconstruction times. In someconfigurations, a pixel size ranging from about 80 µm to about 200 µmwill provide adequate resolution, and that a detector pixel dimensionranging from about 1000 × 1000 pixels up to about 2500 × 2500 pixelswill be appropriate. Other configurations would utilize a detector witha pixel dimension of about 99 µm and about 1500 × 1500 pixels.

The x-ray systems described herein can be controlled by an embeddedprocessor running a version of Windows 10 (or other suitable operatingsystem) that logs the image data, performs basic image processing, andcorrelates each 2D projection with the associated geometric (positionand orientation) information obtained from the integrated geometrictracking system, such as those shown in FIG. 5 . The combined 2Dprojection data can be transmitted using high-speed WiFi (or othersuitable high-speed wireless data transmission means) to an externalcomputer where additional image processing and 3D image reconstructioncan be performed, and where 3D images can be displayed for use by theoperator.

In some configurations, a wireless data transmission method can be usedto convey the 2D projection data from the x-ray system to the externalcomputer in order to eliminate data cables that would potentially get inthe way or otherwise restrict the manipulation of the X-ray imagingsystem during a data acquisition scan. Similarly, the x-ray system canbe battery powered in order to avoid power cables that could similarlyrestrict manipulation of the system.

The x-ray systems described herein can be configured to capture 2Dprojection images at a frame rate sufficient to capture all of the datarequired for reconstruction of the 3D image in a short period of time.An acceptable lower limit on the required framerate is believed to rangefrom about 3 frames per second (fps) up to a rate of about 10 frames persecond or more. The limitations on the image acquisition rate come fromthe possible WiFi data transmission rate, the practical detector dataread-out rate, and the exposure or pulse repetition rate for the X-raysource. Currently, the data acquisition frame rate is primarily limitedby the WiFi data transmission speed. As WiFi technology furtherimproves, though, it is expected that practical image frame rates willclimb to 20 fps or more and speeds up to and perhaps beyond 30 fps willbe possible. At some point the speed at which the system can be guidedby hand along a 2D projection acquisition path will become a limitingfactor for the desirable frame rate because too many 2D projections thatare geometrically too close to each other will not provide significantbenefit in the 3D reconstruction, while exposing the patient tounnecessary radiation dose. For these, and other reasons, it is believedthat the operating frame rate will always be between about 5 fps andabout 20 fps, and in some embodiments might be about 10 fps.

In some embodiments, the size and resolution of the images can beincreased while maintaining the necessary frame rate. These embodimentsutilize an image size of about 1500 × 1500 pixels. Larger images are ofinterest, such as about 1700 × 1700 pixels, or about 2000 × 2000 pixels,or even up to about 3000 × 3000 pixels or more. It is also not necessarythat the image remain square, so video images with dimensions of about1500 × 2000 pixels, or about 2000 × 3000 pixels or other dimensions arealso possible. The technology used could be a CCD array coupled to acesium iodide scintillation plate, or a CCD or CMOS array coupled toother x-ray scintillators such as sodium iodide, zinc selenide, calciumfluoride, and others.

As shown in FIG. 7 and described herein, the source and detector in thex-ray systems can be moved outside a planar acquisition path to scan orsample a region defined by a solid angle. FIG. 8 shows an exemplary 3Dacquisition path, projected in two dimensions, of the x-ray systemsduring one possible data scan. The x-ray source of the C-arm follows thepath 810 along the blue curve shown in the images on the right, and eachred line 820 shows the path from the X-ray source to the detector for aparticular image that can be captured. The upper left image in FIG. 8shows a 3D view of ground truth, or completely accurate actualacquisition path. The upper right image in FIG. 8 shows a 2D projectionof the ground truth acquisition path. The lower left image in Figureshows a 2D projection of the nominal (given) path. And the lower rightimage in FIG. 8 illustrates a 2D projection of the path as estimated atthe beginning of the 3D reconstruction process.

FIGS. 9 and 10 are examples of the 3D image reconstruction that can beobtained using the x-ray systems and methods described herein. FIG. 9shows an axial slice of a 3D image reconstruction with tracking data.The upper left image in FIG. 9 shows a head CT dataset. The upper rightimage in FIG. 9 shows a reconstruction with ground truth parameters. Thelower left image in FIG. 9 shows a reconstruction with nominalparameters. And the lower right image in FIG. 9 shows a reconstructionwith geometry estimation. FIG. 10 shows an axial slice through the CTvolume in the left image and a simulated Digitally Reconstructed 2DRadiograph (DRR) in the right image.

The x-ray systems described herein employ advanced tomosynthesisreconstruction algorithms that can be adapted and improved toreconstruct 3D images at a clinical level of performance despite thegeometry uncertainty and errors that arise from a flexible acquisitiontrajectory using simple mechanical guidance or guidance by hand. Thus,once the 2-D image data is obtained, it can be processed to reconstructthe 3D image using software based on reconstruction algorithms that canaccount for uncertain geometry. Thus, the geometry of the acquisitionscan can be irregular and uncertain and accordingly some conventionalcone-beam reconstruction techniques will not work. While largerisocentric C-arms and fixed C-arms have much more consistent geometry,smaller mobile C-arms do not and are often moved by hand on an imprecisepath. This scenario results in an uncertain geometry that has promptedwork towards algorithms that can deal with these uncertainties orposition and orientation errors.

Any 3D reconstruction technique can be used provided it can account forthis uncertain geometry. For example, the Scientific Computing & ImagingInstitute (SCII) at the University of Utah has proposed a method for 3Dreconstruction in the presence of uncertain geometry. Instead ofassuming a precise geometry based on expensive mechanical systems, thisapproach estimates the true geometry algorithmically whilesimultaneously estimating the 3D image. It is believed that algorithmssuch as that developed by SCII, or other algorithms that implement othermeans for estimating the true geometry in a 3D image reconstruction,while also meeting the requirements for speed and accuracy, will meetthe requirements of the x-ray systems described herein.

The x-ray systems described herein, unlike some conventional approachesthat employ a motion-controlled stage, capture the geometrical positionof each 2D x-ray image as it is taken by the C-arm. The location in 3Dspace where each image is taken is not fixed, predetermined, or measuredby the mechanical action of the motion-controlled stage and/or anyelectronics or positioning actuators that are part of the motion-controlmechanism. Rather, it is measured by the internal tracking devicesincorporated into the C-arm itself or the external tracking devices.This significantly reduces the cost, complexity, and the accuracyrequired of the stage because it is not determining the geometricposition or causing any error in the geometric position of each image.The accuracy of, and any error in, each geometric position isattributable to the tracking devices.

Another improvement over these conventional approaches is that themotion of the stage, whether moved by hand or by a mechanism of somekind, is continuous. The short exposure time capability of the x-raysource (on the order of about 50 milliseconds or less, including about25 ms, 10 ms, or even 5 ms or less) converts the challenge of mechanicalstability and a stop-motion movement driven by a stepper motor or othersimilar device into a simple mechanical movement and a stop-motion imagecapture technique that is similar to taking a photo with a high shutterspeed.

During operation of the x-ray systems described herein, there is atrade-off between the rate of motion of the C-arm during a scan and theneed to keep the patient motionless during the scan. A high rate ofmotion will lead to a faster scan time, thus reducing the time duringwhich the patient must remain substantially motionless. However, if therate of motion is too quick, the resolution of the image will beimpacted because of excessive motion of the x-ray source and thedetector during the exposure time for each frame. Even if this exposuretime is as short as 20 milliseconds, a high rate of motion will resultin the detector or the x-ray source, or both, moving more than 100microns or more during the exposure. This will introduce motion blurinto the 2D image data and therefore may adversely affect the finalrendered 3D image.

The imaging scan should also be completed in a total time frame that isshort enough with respect to the ability of the patient to remainmotionless. If the patient is anesthetized, than a scan that iscompleted in about 20 seconds, or about 30 seconds, or even about 45 orabout 60 seconds may be acceptable. In other situations where thepatient is conscious, a scan time of about 5 seconds, about 10 seconds,or perhaps about 15 seconds is necessary. With proper tomosynthesiscalculation techniques, some small amount of patient motion can beaccounted for, so a time of about 10 or about 15 seconds is probablyacceptable, but for optimum image resolution the scan should becompleted as quickly as possible in light of the trade-off between therate of motion and the total scan time.

One method to determine the time in which a scan can be completed is toconsider the effects of the motion of the x-ray source and detector uponthe image resolution. If, for the sake of illustration, the distancefrom the x-ray source to the detector is about 15 inches (38 cm), andthe object to be imaged is located half-way between the source and thedetector. The motion of both the detector and the source between twoconsecutive image frames can be described as an arc around the objectwith a radius of 7.5 inches (19 cm). In order to avoid an effective lossof resolution on the detector due to motion during the acquisition of animage, the displacement of the detector during the image acquisitionneed not exceed the dimension of a small number of pixels in thedirection of motion. In some embodiments, a limitation of 3 pixels orless can be used. To illustrate further, if the arc of rotation for theC-arm covers 120 degrees, and this arc is scanned within an interval of20 seconds, the angular rate of motion would be 6 degrees per second. Ata radius of 19 cm, this would be equivalent to the detector and thesource both moving at a rate of 1.99 cm per second. If the detectorpixel size is 100 µm, then the detector could be allowed to move by amaximum amount of approximately 300 µm during an image acquisition. Ofcourse, if the detector motion during an image acquisition can belimited to 2 pixels or less, which would correspond to a maximum motionof approximately 200 µm, this would give better results. Given such ascenario, this would mean that each image should be acquired in a timeof about 15 milliseconds.

This exemplary configuration is believed to be a practical exposure timefor an image, though for a given x-ray source (and the associated x-rayflux) and a given x-ray detector (and the associated x-ray detectionsensitivity), other exposure times may be used. In general, it isbelieved that a time of 25 milliseconds or less is preferable for anumber of reasons, including the issues of patient motion as well asmotion of the x-ray source and detector, therefore a time of 25milliseconds, or 20 milliseconds, or 15 milliseconds, or perhaps even aslittle as 10 milliseconds or 5 milliseconds for an exposure may bepreferred, depending on the detailed design of the system and the 3Dimaging application. In other configurations, this time can be anycombination, sub-combination, or range of these amounts.

When scanning in the region of the solid angle, C-arm is first scannedthrough the initial arc described above that lies in a single plane, asillustrated in FIG. 6 . Then the sector bearing for the C-arm can thenbe rotated or shifted through an angle perpendicular to the sector arcand the C-arm would be scanned again. This angle could be optimized forthe application and procedure, and may prove to be different fordifferent imaging requirements. Thus, the total acquisition path wouldsample a region of the solid angle, as shown in FIG. 7 but with adifferent path than the arbitrary path shown in FIG. 7 . A scan angle ofabout 10 degrees, about 20 degrees, about 30 degrees, about 40 degrees,about 50 degrees, about 60 degrees, about 70 degrees, about 80 degrees,about 90 degrees, about 100 degrees, about 110 degrees, and even 120degrees or more could be used. In other embodiments, this path can beany combination, sub-combination, or range of these amounts. Of course,a larger angle will sample a larger region of solid angle so it isdesirable to use as large a scan angle as practical. In someconfigurations, the angle used can be any combination, sub-combination,or range of these amounts. If necessary for the 3D reconstruction, thestage could be shifted to obtain a third (fourth, fifth, or even more)data scan. Shifting the stage and taking multiple scans will providemuch higher z-axis resolution in the reconstructed 3D images. The entirescanning process can be completed in about 20 to about 30 seconds, oreven about 10 seconds or less depending on the time between the scansand the rate of motion of the system.

In some embodiments, the stage of the system can be mounted on alightweight (approximately 100 lbs) hand-mobile cart that would be movedinto position at the side of the operating table when needed. It couldtake around 30 seconds (or less) to position the stage and C-armappropriately with respect to the target area of the patient’s body andinitiate the scan. The entire process of moving the stage into place,positioning the system, gathering the data, and removing the stage couldbe completed within about 3 minutes, about 2.5 minutes, about 2 minutes,about 90 seconds, or even about 60 seconds by a trained surgical team.In other embodiments, this time can be any combination, sub-combination,or range of these amounts.

In some embodiments, the x-ray systems operate while being mounted on amechanical device that guides the source and the detector as they tracea series of arcs that together would generally define a portion of aspherical surface, or in other words, a region of solid angle. This sametype of motion or acquisition path for the system could also be usedwhere the system is hand-held. However, it is not necessary in theseembodiments that the system travel in a series of regular arcs ofconstant radius, as would easily be done with the mechanical device asdescribed. The goal, in both the hand-held and the mountedconfigurations, is to obtain a sufficient number of 2D projection imagesto provide the data adequate for a reconstructed 3D image.

Especially in the hand-held configurations, but also true in the mountedconfigurations, it is not required that the radius (or distance of theX-source or detector from the object) of the region of solid anglecovered during the acquisition scan be held constant, nor is it requiredthat the path through the region of solid angle be a series of arcs. Thepath described by the X-ray source, for example, can be samples orsegments of the region of solid angle, may be similar to a helix, or aspiral, or have the shape for the letter S, or may follow any other pathas it covers the required region of the solid angle. Sufficient 2Dprojection images need to be obtained with sufficient differences intheir solid angle orientation so that the 2D projection data containedin the set of images provides good and sufficient information on the 3Dstructure of the object to enable a successful reconstruction.

Thus, the x-ray systems simplify the mechanical motions required incapturing a 3D x-ray image, eliminate the mechanical constraints andissues entirely if the 3D scan is performed in a hand-held manner, andtake advantage of the capability and performance of modern electronics,graphical processing systems and other high-speed data processors, alongwith advances in x-ray sources and digital x-ray detectors to obtain thenecessary geometric position (and orientation) information and toimplement the mathematical algorithms that can reconstruct a 3D imagefrom the more complex and less exact geometric data set that will beproduced in an scan.

The x-ray systems, devices, and methods described herein would be usefulin analyzing and treating bone fractures. Among all types of non-fatalinjuries, bone fractures are the leading cause of missed work days witha median of 30 days missed per fracture. Fractures, of all types, causemore than 70% of all hospital charges for musculoskeletal injuries inthe US. Clearly, bone fractures are a common injury and have asignificant impact on the typical patient. While data on what percentageof these fracture injuries currently require 3D imaging during treatmentis difficult to find, conversations with orthopedic surgeons indicatethat a quick, low-impact, easy-to-use 3D imaging system would be widelyused in treating fracture injuries in order to avoid misalignments andpositioning defects that are often difficult to detect with just 2Dx-ray images.

During surgery, with only 2D images immediately available except in rareinstances, guesswork is often required in positioning the bones, bonefragments, and joint surfaces involved in an injury or a correctiveprocedure. Often, the surgical repair that was perceived as fullycorrected during the operation will demonstrate defects and changes inthe postoperative x-rays from what was perceived in the OR and from thedesired outcome. These defects and changes are, in large part,attributable to the inability of conventional 2D X-ray image to fullyconvey 3D information to the physician.

Conventionally, 3D images are often obtained using a Cone-beam or aFan-beam X-ray source in which the x-ray source and detector areconfigured to move in tandem around the subject in a planar arc, asshown in FIG. 6 and described above, to obtain the desired projectionimages. The X-ray source and detector complete 360 degrees of rotationdescribing circles in a two-dimensional plane around the subject for thebest reconstruction results with the best resolution for thereconstructed image slice that lies in that same plane. However, in manyinstances, 360 degrees of rotation is not possible for mechanical orother reasons of practicality. Whatever the extent of rotation aroundthe circle in a two-dimensional plane, the resulting set of 2Dprojection images will not provide detailed information on thethree-dimensional structure of the object that lays outside of thattwo-dimensional plane, because projection views of the object that lieonly in a plane cannot provide information on details located outside ofthe plane. Thus, some conventional CT 3D images are often displayed asslices, and CT systems are configured so that the X-ray source anddetector follow a helical path as they rotate around the subject.

There are other known methods for obtaining 2D projections, some ofwhich are described in U.S. Pat. Nos. 9,014,328, 7,333,588, 9,442,083,and 5,625,661. In these methods, a primary concern is to reduce thepatient radiation dose by more effectively using the data provided byeach 2D image projection, and to be able to obtain more accurate orreliable 3D reconstructed images of the object, or the region in thepatient’s body that is of interest.

Despite the advances in 3D X-ray image generation described in thesepatents, they so not described an inexpensive, easy-to-use, 3D imagingsystem and method that enables the 3D imaging device to be sufficientlymobile to be brought to the patient rather than requiring the patient togo to the machine, that does not require dedicated facilities andoperators or expensive image display capability, that makes effectiveuse of the data obtained from the radiation dose delivered to thepatient, and that can provide high-resolution images in X, Y, and Z overa subject volume large enough to be useful for orthopedics or othermedical applications, while sampling a relatively small geometric solidangle rather than just a portion of an arc in a plane. The devices,systems, and methods described herein improve over these, and otherexisting practices and devices, and incorporate unique features andcapabilities to enable the reconstruction of 3D images where the set oftwo-dimensional x-ray images are not constrained in their geometricalconfiguration or geometrical relationship to an arc lying in a plane.Instead, they enable the use of an arbitrary or flexible geometricalpath that traverses a region of solid angle for the x-ray source anddetector during the acquisition of the images. They also reduce, or eveneliminate, the need for complex and expensive mechanical systems thatguide and tightly control the motion of the x-ray source and detectorduring acquisition of the set of 2D x-ray projection images. Thissignificant advance in the technology of 3D X-ray imaging in thedevices, systems, and methods described herein will also reduce thepatient dose and the over-all expense and difficulty in obtaining andusing 3D images in medical practice, such as in orthopedics. Thecapability to reconstruct 3D images for a more flexible or generalizedgeometrical situation enabled by the devices, systems, and methodsdescribed herein greatly increases the applicability and ease-of-use of3D x-ray images.

To obtain these features, the x-ray systems described herein contain anarm (i.e., a c-arm) configured to be moved by hand around an object tobe imaged, a light weight, bright, low power x-ray source attached tothe arm, x-ray detectors synchronized to move with the x-ray source tocapture multiple 2D projection images, a tracking mechanism toaccurately record the location and orientation in three-dimensions ofthe x-ray source and detector at the moment each of the 2D images iscaptured, and an image processor or computer configured to accept themultiple, 2D images with a generalized, non-pre-determined or “fixed”geometry and use a reconstruction algorithm to construct athree-dimensional image of the object. Such a configurations allowcreation of a 3D image of an object where the acquisition scans of theobject are irregular, meaning the physical path in 3-dimensional spacefollowed by the x-ray source and detector to obtain the series of 2Dprojection images, and the relative geometry of each of the 2D images ismuch less constrained than some conventional technologies forreconstructing 3D X-ray images. This does not mean that the geometry ofthe x-ray source and detector are not known, because the trackingmechanism provides complete and adequate information on the location andgeometric orientation of the x-ray source and detector for each x-rayimage relative to the other 2D projections, as well as relative to thesubject being imaged. What is unknown or not known before the x-rayimage scan is made is the exact location and orientation at which each2D X-ray image will be captured. This is a departure from someconventional methods where the geometric location in 3D space at whicheach 2D X-ray image will be captured is known and pre-determined to ahigh degree of accuracy by the complex, carefully-designed, andexpensive mechanical and electronic systems that control the positionand motion of the X-ray source and detector during the X-ray imageacquisition scan. Further, the x-ray devices described herein can bemuch lighter, more maneuverable, and much less expensive because thetracking mechanism, combined with the processor and algorithm, enablesthe generation of 3D images without knowing the precise geometry of each2D projection image to a high degree of accuracy.

The x-ray systems, devices, and methods described herein can containseveral modifications. In some modifications, multiple x-ray sourcesand/or multiple detectors can be used. In other modifications,collimators for the source or collimated detectors can be used. Theimaging systems can also be modified to contain one or more positioncalibration mechanisms with a combination of technologies or otherfeatures. It is even possible that a position calibration mechanism canbe used that will require only one device to be integrated into theX-ray system structure, as long as it provides the requisite positionand orientation information in three-dimensional space.

In addition to any previously indicated modification, numerous othervariations and alternative arrangements may be devised by those skilledin the art without departing from the spirit and scope of thisdescription, and appended claims are intended to cover suchmodifications and arrangements. Thus, while the information has beendescribed above with particularity and detail in connection with what ispresently deemed to be the most practical and preferred aspects, it willbe apparent to those of ordinary skill in the art that numerousmodifications, including, but not limited to, form, function, manner ofoperation and use may be made without departing from the principles andconcepts set forth herein. Also, as used herein, the examples andembodiments, in all respects, are meant to be illustrative only andshould not be construed to be limiting in any manner.

1. An imaging system, comprising: an arm configured to move around anobject to be imaged; an x-ray source configured to move around theobject without being constrained to a pre-determined path; an x-raydetector configured to move in a path complimentary to the x-ray sourceand capture multiple two dimensional (2D) images; tracking devices forcapturing the position of the x-ray source and detector when each 2Dimage is captured; and a processor configured to construct a threedimensional (3D) image from the multiple 2D images using areconstruction algorithm.
 2. The system of claim 1, wherein the trackingdevices are located within the arm near the x-ray source and x-raydetector.
 3. The system of claim 2, wherein an additional trackingdevice is integrated into the arm in a location other than near thex-ray source and x-ray detector.
 4. The system of claim 1, wherein thetracking devices are located external to the arm.
 5. The system of claim4, wherein the tracking devices comprise a fiducial marker.
 6. Thesystem of claim 5, wherein the tracking devices comprise an array offiducial markers.
 7. The system of claim 1, wherein the movement of thex-ray source and x-ray detector are not in a planar arc.
 8. The systemof claim 7, wherein the movement of the x-ray source and x-ray detectorare in a region of a solid angle outside of the planar arc.
 9. Animaging system, comprising: a C-arm configured to move around an objectto be imaged; an x-ray source in a first portion of the C-arm andconfigured to move around the object without being constrained to apre-determined path; an x-ray detector in an opposing portion of theC-arm and configured to move complimentary to the x-ray source tocapture multiple two dimensional (2D) images; tracking devices forcapturing the position of the x-ray source and detector when each 2Dimage is captured; and a processor configured to construct a threedimensional (3D) image from the multiple 2D images using areconstruction algorithm.
 10. The system of claim 9, wherein thetracking devices are located within the arm near the x-ray source andx-ray detector.
 11. The system of claim 10, wherein an additionaltracking device is integrated into the arm in a location other than nearthe x-ray source and x-ray detector.
 12. The system of claim 9, whereinthe tracking devices are located external to the arm.
 13. The system ofclaim 12, wherein the tracking devices comprise a fiducial marker. 14.The system of claim 13, wherein the tracking devices comprise an arrayof fiducial markers.
 15. The system of claim 9, wherein the movement ofthe x-ray source and x-ray detector are not in a planar arc.
 16. Thesystem of claim 15, wherein the movement of the x-ray source and x-raydetector are in a region of a solid angle outside of the planar arc. 17.A method for imaging an object, comprising: providing an x-ray sourceand an x-ray detector on opposing sides of a C-arm; moving the x-raydetector and the x-ray source in a complimentary path around the objectwithout being constrained to a pre-determined path to capture multipletwo dimensional (2D) images; tracking the position of the x-ray sourceand detector when each 2D image is captured; and forming athree-dimensional (3D) image of the object from the multiple 2D imagesusing reconstruction algorithm.
 18. The method of claim 17, whereintracking devices are located external to the C-arm to track thepositions of the x-ray source and x-ray detector.
 19. The method ofclaim 18, wherein the external tracking devices comprise a fiducialmarker.
 20. The method of claim 19, wherein the external trackingdevices comprise an array of fiducial markers.
 21. The method of claim17, wherein the movement of the x-ray source and x-ray detector are notin a planar arc.
 22. The method of claim 17, wherein the movement of thex-ray source and x-ray detector are in a region of a solid angle outsideof the planar arc.